A great challenge in preparing cell culture media lies in the virtually endless choice in recipes with a wide range of components, different bulk densities, particle sizes or flow properties. This requires a universal system that takes into account all of the process steps from formulation, pre-mixing, grinding and post-mixing through to packaging.
The technology from the Hosokawa Group starts immediately after formulation, integrating the core technologies of mixing and grinding into a seamless process. This ensures the production of high-quality media. After formulation, the materials are poured into the pre-mixer. The homogenised material is then dosed into the UPZ fine impact mill. This can be mounted on the post-mixer. That is where collection then occurs, and if necessary further materials can be added. After a further homogenisation step, the end product is packed into the contamination-free packaging unit. The vertical design of the equipment arrangement provides a high degree of flexibility for a large number of formulations:
- Closed loop inert system
- Temperature-controlled grinding (down to -40°C)
- High mixing accuracy
- Closed packaging
- Integrated cleaning
Systems for preparing cell cultures must be flexible and efficient if new batches with different recipes are to be manufactured every day. That is why cleaning options play a decisive role in the selection of suitable process equipment.
Hosokawa mixers and mills are designed to prevent contamination. The vertical, aseptic design with a high-quality surface finish and the conical mixing vessels with a fixed connection to the mill guarantee maximum product recovery.
However, some contamination can simply not be avoided, even if all of the necessary precautions are taken. For this reason, spray nozzles are positioned at strategic locations for wet cleaning of the production line. This wets everything and guarantees a thorough cleaning from top to bottom.
The spray nozzles clean the surfaces using a combination of impact and releasing action: from the pre-mixer and the mill to the post-mixer and the packaging unit. After the wet cleaning process, all of the components are dried from top to bottom with hot air, utilising the stack effect.
The production line is controlled by a fully automatic control system that meets the highest pharmaceutical standards such as FDA, cGMP and GAMP.
Entscheidend ist die Verarbeitung – von der Vormischung bis zur Verpackung – in einem durchgängigen Prozess. Ein integrierter Ansatz zur Prozesslösung ist essenziell. Er verhindert den ungewollten Kontakt mit Sauerstoff, Feuchtigkeit und Keimen der Umgebung. Kurze Verarbeitungszeiten unter konditionierten, kühlen Bedingungen sichern die Qualität der Inhaltsstoffe. Ein hoher Automatisierungsgrad im Prozess – insbesondere bei Reinigung und Trocknung – schafft Sicherheit und Flexibilität und ermöglicht die Herstellung verschiedenster Medien auf einer Anlage, ganz gleich ob in Batchgrößen von wenigen Kilogramm oder im Tonnenmaßstab.
